Coronary Artery DiseaseNCT05461729
TIMELY-PrädiktoR Prospective Study
An observational study of Coronary Artery Disease, run by Dr. Boris Schmitz at 1 site in Germany.
Trial summary
Brief Summary: Cardiac rehabilitation (CR) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (CAD), manage symptoms, and reduce the risk of future cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to 31 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Coronary Artery Disease (CAD) patients participating in phase II Cardiac Rehabilitation (CR).
Who may be able to join
- Coronary Artery Disease (CAD) patients after myocardial infarction (STEMI/NSTEMI) and/or angioplasty and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery bypass graft surgery who participate in phase II Cardiac Rehabilitation (CR).
Who cannot join
- Incapability to give informed consent
- Conditions that prevent patients from participation in CR including unstable coronary or cerebrovascular conditions and acute infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik Königsfeld
Ennepetal, North Rhine-Westphalia, 58256
Frank C Mooren, MD, 004923339888100, Frank.Mooren@uni-wh.de
Boris Schmitz, PhD
About this study
Brief Summary:
Cardiac rehabilitation (CR) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (CAD), manage symptoms, and reduce the risk of future cardiovascular events. CR is a structured program not only addressing CAD but also comorbidities including hypertension, dyslipidemia, diabetes and obesity as well as other risk factors. CR aims at long-term lifestyle changes to reduce modifiable risk factors, and it's success depends on a large number of interacting variables including biological, psychological and social factors. Recently, the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood. The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR. Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data, (central) blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge. Follow-up assessments will be performed at least at 6 months and at 12 months after discharge. Events (MACCE) will be collected for up to 10 years. After 2023, the study will be run under the acronym PrädiktoR.
Read more
Main objectives of the study:
- To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes.
- To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD, also to be used in machine learning models and for the generation of digital twins.
- To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac Rehabilitation, Telemedicine, Healthy Lifestyle, Preventive Programs, Artificial Intelligence, Predictive Medicine, Continuum of Care, Maintenance, Aftercare, eHealth, mHealth
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease | Patients with Coronary Artery Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiorespiratory Fitness (CRF)
CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry
Measured: Baseline, week 3, week 24, and week 48
Change in risk of mortality
Risk of mortality will be determined using the validated biomarker risk score COROPREDICT
Measured: Baseline, week 3, week 24, and week 48
Number of patients with major adverse cardiac and cerebrovascular events (MACCE)
Number of patients with death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization, and major bleeding
Measured: Baseline to week 48, and week 432
Secondary outcomes (36)
Physical activity (PA)
PA will be measured by validated BSA questionnaire (Bewegungs- und Sportaktivität) and expressed as metabolic equivalents
Measured: Baseline, week 3, week 24, and week 48
Daily step count
Steps will be measured using electronic devices such as wrist-worn activity trackers
Measured: Baseline to week 24
Weekly number and duration of physical activities
Number and duration of physical activities will be measured using electronic devices such as wrist-worn activity trackers
Measured: Baseline to week 24
Resting heart rate
Resting heart rate will be measured using electronic devices such as wrist-worn activity trackers
Measured: Baseline to week 24
Sleep duration
Sleep duration will be measured using electronic devices such as wrist-worn activity trackers
Measured: Baseline to week 24
Physiological stress
Physiological stress will be measured using electronic devices such as wrist-worn activity trackers
Measured: Baseline to week 24
Blood pressure
Central and peripheral systolic and diastolic blood pressure will be measured using automatic upper-arm sphygmomanometers. Data transmitted by telemetry.
Measured: Baseline to week 24
Arterial pressure wave propagation/reflection characteristics
Arterial pressure wave propagation/reflection characteristics will be measured using automatic upper-arm tonometry. Data transmitted by telemetry.
Measured: Baseline to week 24
Cardiac arrhythmia
Cardiac arrhythmia will be measured using three-channel Holter ECG.
Measured: Baseline to week 24
Body composition
Body composition including fat mass, muscle mass, and visceral fat area will be measured by bioimpedance analysis.
Measured: Baseline, week 3, and week 24, and week 48
Muscle strength
Arm and leg extension and flexion strength will be measured using Isokinetic devices
Measured: Baseline, week 3, and week 24
Muscle function
Muscle function will be measured by 30-second chair rise test
Measured: Baseline, week 3, and week 24, and week 48
Submaximal exercise capacity
Submaximal exercise capacity will be measured using 6-min walking test
Measured: Baseline, week 3, and week 24, and week 48
Habit formation
Habit formation will be assessed using validated questionnaire for the "Self-Report Behavioural Automaticity Index (SRBAI)".
Measured: Baseline, week 3, week 24, and week 48
Nicotine dependence
Nicotine dependence will be assessed using the Fagerström questionnaire
Measured: Baseline, week 3, week 24, and week 48
Cardiac Self-Efficacy
Cardiac Self-Efficacy will be assessed using the validated "Cardiac Self-Efficacy Scale (CSE)"
Measured: Baseline, week 3, week 24, and week 48
Impact of disease
Impact of disease will be assessed using the "brief illness perception (IPQ-9)" questionnaire .
Measured: Baseline, week 3, week 24, and week 48
General wellbeing
General wellbeing will be assessed using the "Positive And Negative Affect Scale (PANAS)" questionnaire .
Measured: Baseline, week 3, week 24, and week 48
Fear of Activity/ Kinesiophobia
Fear of Activity/ Kinesiophobia will be assessed using the modified "Fear of Activity Scale (FActS)".
Measured: Baseline, week 3, week 24, and week 48
Depression
Depression will be assessed using the modified "Patient Health Questionnaire (PHQ-9)".
Measured: Baseline, week 3, week 24, and week 48
General anxiety
General anxiety will be assessed using the "7-item General Anxiety Scale (GAD-7)".
Measured: Baseline, week 3, week 24, and week 48
Health-related quality of life
Health-related quality of life will be assessed using the "RAND 36-Item Health Survey (SF-36)".
Measured: Baseline, week 3, week 24, and week 48
General quality of life
Quality of life will be assessed using the "5-level EQ-5D (EQ-5D-5L) health status measure".
Measured: Baseline, week 3, week 24, and week 48
Wellbeing
Wellbeing will be assessed using the "WHO-5 Well-Being Index".
Measured: Baseline, week 3, week 24, and week 48
Perceived stress
Perceived stress will be assessed using the "Perceived Stress Scale (PSS-4)".
Measured: Baseline, week 3, week 24, and week 48
Optimism/ Pessimism
Optimism/ Pessimism will be assessed using the modified "Life Orientation Test (LOT-R)".
Measured: Baseline, week 3, week 24, and week 48
Conscientiousness
Conscientiousness will be assessed using the "The Big Five Inventor (BFI-10)".
Measured: Baseline, week 3, week 24, and week 48
Psychological flexibility
Psychological flexibility will be assessed using the psychometric properties of the "Acceptance and Action Questionnaire-I (AAQ-II)".
Measured: Baseline, week 3, week 24, and week 48
Negative Affectivity
Standard assessment of negative affectivity, social inhibition, and Type D personality (DS-14)
Measured: Baseline, week 3, week 24, and week 48
Trait anger
Trait anger will be assessed using the "State-Trait Anger Expression Inventory-2 ("TAI-10/STAXI-2").
Measured: Baseline, week 3, week 24, and week 48
Religiousness/ spirituality
Religiousness/ spirituality will be assessed using the "Spiritual and Religious Attitudes in Dealing with Illness (GrAw-7/ SpREUK-15)" questionnaire.
Measured: Baseline, week 3, week 24, and week 48
Fatigue
Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".
Measured: Baseline, week 3, week 24, and week 48
Psychological situation in the working environment
Psychological situation in the working environment will be assessed using the "The effort-reward imbalance model (ERI10+6)".
Measured: Baseline, week 3, week 24, and week 48
Work requirements and workload
Work requirements and workload will be assessed using the "Workability Index (WAI)".
Measured: Baseline, week 3, week 24, and week 48
Social support
Social support will be assessed using the short "Perceived Social Support Questionnaire (F-SozU K6)".
Measured: Baseline, week 3, week 24, and week 48
Relationship satisfaction
Relationship satisfaction will be assessed using the "Quality of Marriage Index (QMI)".
Measured: Baseline, week 3, week 24, and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Jun 2021
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Boris Schmitz
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, University of Amsterdam, Technische Universität Dresden, MEDIZINISCHE UNIVERSITAT GRAZ, Stichting Katholieke Universiteit, Foundation for Research and Technology - Hellas
- Responsible party
- Sponsor-investigator, Dr. Boris Schmitz, University of Witten/Herdecke
- Investigators
- Boris Schmitz, PhD, Principal investigator, University of Witten/Herdecke, Dpt. Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461729
- Sponsor's protocol ID
- TIMELY_P01
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmitz B, Wirtz S, Sestayo-Fernandez M, Schafer H, Douma ER, Alonso Vazquez M, Gonzalez-Salvado V, Habibovic M, Gatsios D, Kop WJ, Pena-Gil C, Mooren F. Living Lab Data of Patient Needs and Expectations for eHealth-Based Cardiac Rehabilitation in Germany and Spain From the TIMELY Study: Cross-Sectional Analysis. J Med Internet Res. 2024 Feb 22;26:e53991. doi: 10.2196/53991.
PubMed 38386376
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIMELY-PrädiktoR Prospective Study
- ClinicalTrials.gov ID
- NCT05461729
- Acronym / sponsor ID
- TIMELY_P01
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac Rehabilitation, Telemedicine, Healthy Lifestyle, Preventive Programs, Artificial Intelligence, Predictive Medicine, Continuum of Care, Maintenance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Dr. Boris SchmitzUniversity, hospital or other
- Collaborators
- European Commission, University of Amsterdam, Technische Universität Dresden, MEDIZINISCHE UNIVERSITAT GRAZ, Stichting Katholieke Universiteit, Foundation for Research and Technology - Hellas
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary:
Cardiac rehabilitation (CR) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (CAD), manage symptoms, and reduce the risk of future cardiovascular events. CR is a structured program not only addressing CAD but also comorbidities including hypertension, dyslipidemia, diabetes and obesity as well as other risk factors. CR aims at long-term lifestyle changes to reduce modifiable risk factors, and it's success depends on a large number of interacting variables including biological, psychological and social factors. Recently, the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood. The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR. Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data, (central) blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge. Follow-up assessments will be performed at least at 6 months and at 12 months after discharge. Events (MACCE) will be collected for up to 10 years. After 2023, the study will be run under the acronym PrädiktoR.
Main objectives of the study:
- To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes.
- To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD, also to be used in machine learning models and for the generation of digital twins.
- To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease | – | –Patients with Coronary Artery Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary Artery Disease (CAD) patients participating in phase II Cardiac Rehabilitation (CR).
Key inclusion criteria (1 listed)
- Coronary Artery Disease (CAD) patients after myocardial infarction (STEMI/NSTEMI) and/or angioplasty and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery bypass graft surgery who participate in phase II Cardiac Rehabilitation (CR).
Key exclusion criteria (2 listed)
- Incapability to give informed consent
- Conditions that prevent patients from participation in CR including unstable coronary or cerebrovascular conditions and acute infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Cardiorespiratory Fitness (CRF)
Time frame: Baseline, week 3, week 24, and week 48
CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry
Change in risk of mortality
Time frame: Baseline, week 3, week 24, and week 48
Risk of mortality will be determined using the validated biomarker risk score COROPREDICT
Number of patients with major adverse cardiac and cerebrovascular events (MACCE)
Time frame: Baseline to week 48, and week 432
Number of patients with death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization, and major bleeding
36 secondary outcomes
Physical activity (PA)
Time frame: Baseline, week 3, week 24, and week 48
Daily step count
Time frame: Baseline to week 24
Weekly number and duration of physical activities
Time frame: Baseline to week 24
Resting heart rate
Time frame: Baseline to week 24
Sleep duration
Time frame: Baseline to week 24
Physiological stress
Time frame: Baseline to week 24
Blood pressure
Time frame: Baseline to week 24
Arterial pressure wave propagation/reflection characteristics
Time frame: Baseline to week 24
Cardiac arrhythmia
Time frame: Baseline to week 24
Body composition
Time frame: Baseline, week 3, and week 24, and week 48
Muscle strength
Time frame: Baseline, week 3, and week 24
Muscle function
Time frame: Baseline, week 3, and week 24, and week 48
Submaximal exercise capacity
Time frame: Baseline, week 3, and week 24, and week 48
Habit formation
Time frame: Baseline, week 3, week 24, and week 48
Nicotine dependence
Time frame: Baseline, week 3, week 24, and week 48
Cardiac Self-Efficacy
Time frame: Baseline, week 3, week 24, and week 48
Impact of disease
Time frame: Baseline, week 3, week 24, and week 48
General wellbeing
Time frame: Baseline, week 3, week 24, and week 48
Fear of Activity/ Kinesiophobia
Time frame: Baseline, week 3, week 24, and week 48
Depression
Time frame: Baseline, week 3, week 24, and week 48
General anxiety
Time frame: Baseline, week 3, week 24, and week 48
Health-related quality of life
Time frame: Baseline, week 3, week 24, and week 48
General quality of life
Time frame: Baseline, week 3, week 24, and week 48
Wellbeing
Time frame: Baseline, week 3, week 24, and week 48
Perceived stress
Time frame: Baseline, week 3, week 24, and week 48
Optimism/ Pessimism
Time frame: Baseline, week 3, week 24, and week 48
Conscientiousness
Time frame: Baseline, week 3, week 24, and week 48
Psychological flexibility
Time frame: Baseline, week 3, week 24, and week 48
Negative Affectivity
Time frame: Baseline, week 3, week 24, and week 48
Trait anger
Time frame: Baseline, week 3, week 24, and week 48
Religiousness/ spirituality
Time frame: Baseline, week 3, week 24, and week 48
Fatigue
Time frame: Baseline, week 3, week 24, and week 48
Psychological situation in the working environment
Time frame: Baseline, week 3, week 24, and week 48
Work requirements and workload
Time frame: Baseline, week 3, week 24, and week 48
Social support
Time frame: Baseline, week 3, week 24, and week 48
Relationship satisfaction
Time frame: Baseline, week 3, week 24, and week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 38386376Schmitz B, Wirtz S, Sestayo-Fernandez M, Schafer H, Douma ER, Alonso Vazquez M, Gonzalez-Salvado V, Habibovic M, Gatsios D, Kop WJ, Pena-Gil C, Mooren F. Living Lab Data of Patient Needs and Expectations for eHealth-Based Cardiac Rehabilitation in Germany and Spain From the TIMELY Study: Cross-Sectional Analysis. J Med Internet Res. 2024 Feb 22;26:e53991. doi: 10.2196/53991.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Boris Schmitz, PhD principal investigator
University of Witten/Herdecke, Dpt. Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Dr. Boris Schmitz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boris Schmitz, PhD (004923339888156, boris.schmitz@uni-wh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiorespiratory Fitness (CRF) (time frame: Baseline, week 3, week 24, and week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.